Set, Transfer (Blood/Plasma)
This device is a blood and plasma transfer set, consisting of tubing and associated connectors used to transfer blood or plasma between containers during collection, processing, or transfusion procedures in blood banking settings. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSB, regulated under 21 CFR 864.9875 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSB
- Device Class
- FDA class 2
- Regulation Number
- 864.9875
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Sep 28, 2018 | Substantially Equivalent | Kawasumi Laboratories, Inc. |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | May 19, 2000 | Substantially Equivalent | Kawasumi Laboratories America, Inc. |
| K820447 | ALPHA PLASMA TRANSFER SET | Apr 14, 1982 | Substantially Equivalent | Alpha Therapeutic Corp. |
| K802940 | SUPER-SPIKE TRANSFER SET | Jan 15, 1981 | Substantially Equivalent | Geneva Laboratories, Inc. |
| K791131 | FLU VEN TR-1 | Sep 04, 1979 | Substantially Equivalent | Venospital, Inc. |
| K791130 | FLU-VEN TK-2 | Sep 04, 1979 | Substantially Equivalent | Venospital, Inc. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.